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Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.

Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. - T4/M1LYM DCF PI/II study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003370
Enrollment
30
Registered
2010-03-25
Start date
2009-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal neoplasm

Interventions

docetaxel 70 mg/m2/day day1 iv cisplatin 70 mg/m2/day day1 iv 5-fluorouracil 750 mg/m2/day day1-5 civ q3w , 3 cycle 5-fluorouracil 700mg/m2/day day1-5 civ cisplatin 70mg/m2/day day1 RT 60Gy/30f

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) radiologist permits curative radiotherapy 60Gy 4) with T4 tumors and/or distant lymph node metastasis (M1LYM) 5) no lymph nodes more distant than the celiac region in the abdomen/no distant organ metastases 6) no esophagobronchial fistulas/no esophagomediastinal fistulas, 7) Aged 20 to 70 years old 8) ECOG PS of 0 or 1 9) no previous treatment of esophageal cancer without endoscopic resection 10) no previous chemotherapy or radiotherapy against any other malignancies 11) adequate organ functions 12) written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential 3) Psychosis 4) Patients requiring systemic steroids medication 5) HBs antigen positive 6) Uncontrollable diabetes millutus 7) History of myocardial infarction within three months 8) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema 9) Active bacterial or fungous infection

Design outcomes

Primary

MeasureTime frame
Complete response rate

Countries

Japan

Contacts

Public ContactHironaga SATAKE,MD

National Cancer Center Hospital East Division of Digestive Endoscopy and GI Oncology

hsatake@east.ncc.go.jp078-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026